Kornimate/medical-research-clean huggingface dataset:
ovca-nac-p2: study of chemotherapy followed by cytoreductive surgery for ovarian, tubal and peritoneal cancers: jcog0206

Conditions: Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Summary: a feasibility study of neoadjuvant chemotherapy (nac) followed by interval cytoreductive surgery (ics) and postoperative chemotherapy for stage iii/iv mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas.

the purposes are to assess the safety and efficacy of the treatment starting with nac and to know whether we can accurately diagnose these advanced carcinomas by imaging studies, cytologic findings and tumor markers without staging laparotomy or laparoscopy. fifty-six patients with advanced mullerian carcinomas will be recruited to the study. after confirmation of diagnosis by laparoscopic inspection and biopsies, patients undergo 4 cycles of chemotherapy as nac followed by ics and additional 4 cycles of postsurgical chemotherapy. the primary endpoint is proportion of clinical complete remission after accomplishment of the protocol treatment and the major secondary endpoint is positive predictive value of diagnosis before laparoscopy regarding tumor origin, histology and stage. based on the result of this study, we will conduct a phase iii study to compare the treatment starting with nac and primary cytoreductive surgery followed by postsurgical chemotherapy.

Eligibility criteria:
inclusion criteria: * stage iii or iv müllerian carcinoma by prelaparoscopic clinical findings including imaging studies (ct, mri or ultrasonography) * cytology of ascites, pleural effusions, or fluids obtained by tumor centesis * malignancies of other origins, such as breasts and digestive tract, should be excluded by endoscopy, opaque enema, or ultrasonography when these malignancies are suspected from symptoms, physical examinations or imaging diagnosis. * ca125\>200u/ml and cea\<20ng/ml. * clinically deemed to be a candidate for debulking surgery without evidence of brain, bone, bone marrow metastases, multiple lung, or multiple liver metastases * presence of at least one measurable lesion * previously untreated for these malignancies and no history of treatment with chemotherapy or radiotherapy even for other diseases * eastern cooperative oncology group (ecog) performance status of 0 to 3, * adequate bone marrow, hepatic, renal, cardiac and respiratory functions, and * written informed consent. exclusion criteria: * synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ * pregnant or nursing * severe mental disorders * systemic and continuous use of steroidal drugs * active infections * uncontrolled hypertension * diabetes mellitus, uncontrolled or controlled with insulin * history of cardiac failure, unstable angina, myocardial infarction within 6 months prior to the registration * liver cirrhosis or bleeding tendency contraindicating debulking surgery * intestinal occlusion necessary for surgical treatment * hypersensitivity to alcohol

Keywords: ovarian neoplasms laparoscopy neoadjuvant therapy interval cytoreductive surgery
vitamin d testing and treatment for covid 19

Conditions: Covid 19; Vitamin D Deficiency

Summary: this study will measure vitamin d levels in adults with covid 19. participants with low levels of vitamin d will be entered into an open label trial of supplementation with vitamin d.

protocol for part 1: * a single blood draw at scnm to measure levels of vitamin d and other nutrients, comprehensive metabolic panel, and complete blood count with differential * completing a medical history/symptom form * completing a form about covid-19 symptoms every 2 weeks for 6 weeks * authorization for release of medical records related to covid 19 testing and/or treatment. protocol for part 2: * take a vitamin d supplement daily for two weeks, at a dosage of 10,000 iu/day b.i.d. (age 18-69 years) or 15,000 iu/day t.i.d. (age 70+) * after two weeks of taking vitamin d, return to scnm for a blood draw to remeasure levels of vitamin d, comprehensive metabolic panel, and complete blood count with differential. if vitamin d levels are still below 30 ng/ml, continue the dosage for 3 more weeks. if vitamin d levels are 30-49 ng/ml, continue at a dosage of 5000 iu/day. if vitamin d levels are 50+ ng/ml, stop supplementation. * completing questionnaires about covid 19 symptoms at 2, 4, and 6 weeks after treatment begins (5 minutes each time).

Eligibility criteria:
inclusion criteria for part 1 (testing): 1. adult age 18 or older 2. previous positive test result for covid 19 3. able to communicate clearly in english exclusion criteria for part 1 (testing): none inclusion criteria for part 2 (vitamin d supplementation) 1. participation in part 1 2. vitamin d level below 30 ng/ml 3. no abnormalities on the comprehensive metabolic panel that are clinically significant to increasing the risk of an adverse reaction to vitamin d supplementation exclusion criteria for part 2 (vitamin d supplementation): 1. liver impairment 2. clinical opinion of study physician that vitamin d supplementation could be harmful to the participant. 3. pregnancy 4. no symptoms for 2 weeks after positive covid 19 test 5. recovered from symptoms
somatization, anxiety, and disordered sleep in pediatric eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: eosinophilic esophagitis

in order to decrease disease burden and the perception of disease burden, investigators need to understand the symptoms and severity of anxiety, disordered sleep, and somatization and how these parameters align with symptoms and quality of life in pediatric eoe. to assess the burden of these parameters in children with eoe, investigators will conduct a single center pilot study of 60 children with eoe using validated indexes for anxiety (state trait anxiety inventory for children), somatization (children's somatization inventory), sleep (pediatric sleep questionnaire), coping (connor-davidson resilience score) symptoms (peessv2.0), and quality of life (pedsql-eoe).

Eligibility criteria:
inclusion criteria: * age 8-18 years old * ability to understand and complete the surveys and complete them in english * known diagnosis of eoe defined as \> 15 eosinophils per high power field. patient can have active or inactive disease at the time of entry exclusion criteria: * \ 18 years old * inability to read the surveys in english * concurrent gastrointestinal diseases such as inflammatory bowel disease or celiac disease.

Keywords: eoe
evaluation of a pneumotachograph (spi) for the production of pet and ct acquisitions synchronized with breath for the assessment of extension of lung cancer

Conditions: Non Small Cell Lung Cancer; Lung Nodule

Summary: this is a pilot study, single-center, prospective, open-label, to assess the acceptability and performance of the experimental medical device (spi) used during an imaging examination (pet / ct 4d imaging in synchronized mode centered on the thorax). each patient will be its own control, since the imaging examination will be synchronized simultaneously with the two systems: tested medical device (spi) and reference medical device(rpm).


Eligibility criteria:
inclusion criteria: 1. patient for whom there is an indication of pet/ct 18fdg imaging for thoracic oncology ; this indication is consistent with the standard options recommendations or was validated during multidisciplinary consultation meeting : * either an extension assessment of non-small cell lung cancer; * either the characterization of single pulmonary nodule; or - the definition of the target volume in radiotherapy. 2. patient who meets the following criteria to be eligible for an pet/ct imaging: * patient able to maintain a supine position for 60 minutes * patient with no bronchopulmonary infection and with no upper aero digestive tract acute infection in progress (increased risk of false positives) 3. age ≥ 18 years 4. who ≤ 1 5. well-informed written consent signed by the patient and collected before any specific procedure in the study 6. patient member in a national insurance scheme exclusion criteria: 1. patient with a bronchial carcinoid or bronchoalveolar cancer 2. patient with acute bronchopneumopathy 3. not stabilized diabetic patient 4. patient with an absolute indication against spirometry: ongoing pneumothorax or within the previous month, pleural biopsy or puncture within the previous month, hemoptysis, severe asthma, tuberculosis 5. any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain 6. any usual formal indication against imaging examination pet/ct (important claustrophobia) 7. patient unable to follow study procedures 8. pregnant women or nursing mothers can not participate in the study 9. men and women of childbearing age must use effective contraception at study entry and throughout the study 10. any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator 11. patient under legal guardianship

Keywords: lung cancer pet/ct fdg respiratory synchronization
sex differences in the effects of breaking up sedentary behavior on vascular function in type 2 diabetes

Conditions: Type 2 Diabetes; Cardiovascular Diseases

Summary: type 2 diabetes (t2d) confers a high risk of cardiovascular disease (cvd), particularly among older adults who tend to be physically inactive. prolonged sedentary behavior (sb) has been shown to negatively influence markers of cardiovascular risk (e.g., blood glucose, blood pressure), even among individuals who are physically active. most studies that have examined the effects of breaking up sb have focused on young healthy males and prioritized glycemic outcomes. additionally, sex differences in these outcomes have not been adequately examined. the present study will address these gaps. this 3-arm crossover randomized controlled trial will compare the effects of 3 sb conditions on markers of vascular function. the 3 conditions are: 1) 4 hours of prolonged sb, 2) 4 hours of sb broken up by 5 minutes of self-paced walking every hour, and 3) 4 hours of sb with one 20-minute bout of self-paced walking. in addition to examining the overall effects of each condition, sex differences in physiological responses will be evaluated.


Eligibility criteria:
inclusion criteria: * age ≥60 years * postmenopausal (females only, ≥12 months without a menstrual period) * type 2 diabetes (hemoglobin a1c ≥6.5% and/or previous diagnosis of type 2 diabetes) * ≥6 hours/day sedentary (assessed via ipaq) * willingness to abstain from food, caffeine, alcohol and exercise for \>= 24 hours, and tobacco/smoking for ≥12 hours prior to each intervention visit * ability to speak and read english exclusion criteria: * type 1 diabetes * uncontrolled hypertension (resting systolic ≥160 or diastolic ≥110 mmhg) * initiation of hormone therapy or change in hormone therapy dose/frequency/route of administration in the previous 3 months * renal dialysis * history of deep vein thrombosis (dvt) * evidence of cognitive impairment that could impact ability to consent and/or participation (mini-cog score \<3) * achieving physical activity guidelines (≥150 minutes of mvpa/week, assessed via ipaq)) * physical impairment or disability that interferes with ability to engage in pa (e.g., severe osteoarthritis, lower extremity amputation \[other than toe(s)/partial foot\], use of a walker or wheelchair, etc.), * unstable medical/psychiatric condition that could impact study participation
acute effect of teriparatide with bisphosphonate or denosumab on bone resorption

Conditions: Postmenopausal Osteoporosis

Summary: the aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.


Eligibility criteria:
inclusion criteria: must satisfy a and b and c below: a. women aged 45+ b. postmenopausal c. osteoporotic with high risk of fracture exclusion criteria: * history of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system * current alcohol or substance abuse * major psychiatric disorders * abnormal calcium level, elevated pth, vitamin d deficiency, or anemia * known congenital or acquired bone disease other than osteoporosis * current use or past use in the past 12 months of oral bisphosphonates * current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin * use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months * any current or previous use of strontium or intravenous bisphosphonates * sensitivity to cell-derived drug products or teriparatide * extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months * inability to sit upright for 30 minutes * esophageal abnormalities

Keywords: osteoporosis postmenopausal denosumab teriparatide alendronate forteo® prolia®
comt on aspirin platelets effects (cape)

Conditions: Cardiovascular Diseases

Summary: specific aim i: examine the role of genetic variation in comt on platelet function in a blinded, randomized, placebo controlled clinical trial of daily placebo or aspirin (81mg) for 10 ± 3 days. platelet function will be assessed with platelet aggregometry and by fluorescence-activated cell sorting (facs) of platelet adhesion molecules p-selectin and gpiib/iiia in platelets activated with arachidonic acid, thrombin, collagen, epinephrine and adp. specific aim ii: examine the effects of platelet releasates harvested at the end of each treatment arm on angiogenesis.

this is a randomized double-blinded, placebo controlled study. this study is designed to detect the variation in platelet function based on comt variation and how these platelets respond to cancerous cells. we expect to recruit 60 healthy participants with the intention of studying 45 participants to complete the protocol. individuals aged 18 to 40 years will be eligible to participate in this study if they do not have history of fainting/problems related to blood draws, major chronic medical illnesses, regular or current treatment of aspirin™. examine the role of genetic variation in in catechol-o-methyltransferase (comt) on platelet function in a randomized double-blinded placebo controlled clinical trial of daily aspirin™ (81 mg) versus placebo over 10-14 days. platelet function will be assessed with a platelet aggregometry and by fluorescence-activated cell sorting assessment of platelet adhesion molecule gpiiib/iiia and p-selectin.

Eligibility criteria:
inclusion criteria: * healthy, 18-40 years exclusion criteria: * taking aspirin. smoking, pregnancy, history of cancer of cardiovascular disease. mental illness.
internet-delivered psychological treatment for cancer survivors

Conditions: Cancer Survivors; Anxiety; Depression

Summary: negative psychological effects of cancer are common, but cancer survivors are rarely offered structured psychological treatment. internet-delivered treatments have shown some promise, but specific treatment components have not been empirically evaluated which means that it is not clear which therapies that should be prioritized. in this randomized factorial trial at karolinska institutet, stockholm, sweden, 400 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address the negative psychological long-term effects of cancer. the aim is to determine the contribution of treatment components to the overall effect.


Eligibility criteria:
inclusion criteria: * cancer survivor at least 0.5 years after main therapy * clinically significant anxiety or depression (patient health questionnaire 9 \[phq-9\]≥10, or generalized anxiety disorder 7 \[gad-7\]≥8, or 9-item fear of cancer recurrence inventory \[fcri-9\]≥16) * at least 18 years old * resident of region stockholms, västra götalandsregionen, or region skåne, sweden (listed and de facto) * sufficient technical knowledge and knowledge of the swedish language to take part in a text-based online treatment * continuous access to an electronic device that can be used to access the study web platform exclusion criteria: * recurrent thoughts of suicide, as based on clinical judgement aided by the structured interview and the self-report version of the montgomery-åsberg depression rating scale (madrs-s) item 9 * severe medical condition (e.g., very poor prognosis, stage iv cancer), severe psychiatric disorder (e.g., psychotic disorder, bipolar disorder, or severely debilitating substance use disorder, severe depression), or medical treatment (e.g., chemotherapy, immunotherapy, radiotherapy) that makes the treatment unfeasible * other ongoing psychological treatment * continuous psychotropic medication not stable for the past 4 weeks, or not expected to remain stable during the treatment period * planned absence for more than one week of the intended treatment period * no complete the pre-treatment assessment

Keywords: psycho-oncology randomized factorial trial internet-delivered cognitive behavior therapy
multidisciplinary design to optimize schizophrenia treatment based on multi-omics data and systems biology analysis

Conditions: Schizophrenia; Treatment-resistant Schizophrenia; Side Effect; Lipid Metabolism Disorders; Diabetes; NAFLD; Psychosis

Summary: schizomics is a phase iv, multicenter, dose-flexible, open-label, randomized controlled clinical trial to evaluate the efficacy and safety of aripiprazole versus paliperidone using multi-omics data in patients with a first psychotic episode. the trial will include a total of 244 patients, with two arms of treatment with paliperidone and aripiprazole (1:1). the main objectives of the study are: 1. to compare the efficacy and safety of aripiprazole and paliperidone in the treatment of first episode psychosis (fep) subjects in real-world clinical settings at 3 months. 2. to elucidate whether non-responders after 3 months of adequate treatment may display different molecular signatures at baseline based on multi omics data and systems biology analysis. 3. to uncover whether the appearance of side effects after 1 year of adequate treatment may be related to different molecular signatures based on multi-omics data and lifestyle phenotype using systems biology analysis.


Eligibility criteria:
inclusion criteria: 1. 15-40 years; 2. living in the catchment area; 3. experiencing a first episode of psychosis; 4. no prior treatment with antipsychotic medication or, if previously treated, a total lifetime of adequate antipsychotic treatment of less than 6 weeks; 5. diagnostic and statistical manual of mental disorders fth edition (dsm-5) criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder. exclusion criteria: 1. meeting dsm-5 criteria for drug dependence; 2. meeting dsm-iv criteria for mental retardation; 3. having a history of neurological disease or head injury.
whole blood bactericidal activity (wba) against mycobacterium tuberculosis of faropenem plus amoxicillin/clavulanic acid in healthy volunteers

Conditions: Tuberculosis

Summary: the purpose of this study is to evaluate the bactericidal activity against mycobacterium tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. pharmacokinetics (pk) and whole blood bactericidal activity (wba) will be measured in healthy volunteers following single doses of faropenem plus amoxicillin/clavulanic acid.

wba is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial killing. if performed in parallel with pk measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. the aim of this trial is to investigate the bactericidal activity of faropenem administered with amoxicillin/clavulanic acid (augmentin) using the wba model. we will also explore whether there is any additive effect or synergy with rifampicin in this model. the activity of faropenem on wba by different strains of m. tuberculosis will be compared and the relationship between the host immune profile and wba will be assessed.

Eligibility criteria:
inclusion criteria: 1. aged 21 and above 2. male or female willing to comply with the study visits and procedures 3. willing and able to provide written informed consent exclusion criteria: 1. women who are currently pregnant or breastfeeding 2. signs of active tb 3. previous hypersensitivity or allergy to rifampicin, faropenem or other beta-lactam drugs (penicillins, carbapenems) 4. current use of any drugs or medications known to have an interaction with any of the study drugs 5. current use of any other drugs, over the counter or herbal preparations that are known or potential inhibitors or inducers of cytochrome p450 enzymes 6. evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations 7. known hepatic disease or alcohol abuse 8. any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial 9. current participation in other clinical intervention trial or research protocol

Keywords: tuberculosis whole blood bactericidal activity wba faropenem
the effect of pessary post vaginal prolapse repair, for one month, to reduce the recurrence rate of prolapse

Conditions: Use of Pessary Reduce the Number of Prolapse Recurrence; Uterine Prolapse; Cystocele; Rectocele

Summary: genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. about half of them will require surgical repair for the prolapse, with or without hysterectomy. of these patients about 30-40% will have recurrence of the prolapse, which in some cases requires second operation. in this study the investigators want to investigate whether a vaginal pessary inserting in the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.

all patients going for vaginal surgery for genital prolapse, stage 3-4, with cystocele, rectocele or uterine cervix prominent from the vagina. these patients, after signing an informed consent, a vaginal pessary will insert at the end of the operation and will stay for 4 weeks post-op. after 4 weeks the pessary will be removed, and the patient will followed for 2 years, for recurrence of prolapse.

Eligibility criteria:
inclusion criteria: * all healthy patients with genital prolapse grade 3-4, going for vaginal surgery * age 30-80years exclusion criteria: * patients with pelvic inflammatory disease * patients after pelvic irradiation * large vaginal erosion * vaginal bleeding uncontrolled or undiagnosed * patients going for surgery with mesh